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Irritable Bowel SyndromeNCT00706758

Structured Patient Education Versus Written Information for Patients With Irritable Bowel Syndrome

A study testing IBS school and IBS-guidebook in people with Irritable Bowel Syndrome, run by Sahlgrenska University Hospital at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this randomized controlled study in patients with irritable bowel syndrome (IBS) we plan to compare the effects of a structured patient group education (IBS school) with receiving only written information in the form of a IBS-guidebook. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Irritable Bowel Syndrome
What is being tested?
IBS school and IBS-guidebook
Could I receive a placebo?
No, everyone receives an active treatment
How many people
143 participants
Where
1 siteSweden
Study dates
Aug 2004to Jun 2008
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women 18 to 70 years old, with IBS according to the Rome II criteria
  • Written informed consent

Who cannot join

  • An organic GI disease and/or with another disease potentially affecting the GI symptoms
  • Severe psychiatric disease

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Dept of Internal Medicine, Sahlgrenska University Hospital

    Gothenburg, 41345

Other trials in Sweden

About this study

In this randomized controlled study in patients with irritable bowel syndrome (IBS) we plan to compare the effects of a structured patient group education (IBS school) with receiving only written information in the form of a IBS-guidebook. The effects of the interventions on GI and psychological symptom severity, knowledge and quality of life will be assessed with validated questionnaires at baseline and 3 and 6 months after the intervention.

Read the detailed description

In this randomized controlled study in patients with irritable bowel syndrome (IBS) we plan to compare the effects of a structured patient group education (IBS school) with receiving only written information in the form of a IBS-guidebook. We plan to include men and women 18 to 70 years old, with IBS according to the Rome II criteria, who are referred from physicians in primary care and secondary/tertiary care to participate in the study. The education will be held at the GI out patient clinic at Sahlgrenska University hospital in Gothenburg. A nurse, specialized in GI functional disorders will conduct an interview with each patient for about 30 minutes to collect additional information from the patients before inclusion. The patients will be informed about the positive results obtained in previous studies with both interventions, i.e. a structured patient education (IBS school) and a self-help guidebook. Patients with an organic GI disease and/or with another disease potentially affecting the GI symptoms were excluded. Likewise, patients with a severe psychiatric disease were excluded due to potential problems to participate in a group intervention. In order to allocate an equal number of patients to both of the interventions during the study, a number of up to 20 patients will be interviewed in a block during one week. After all these interviews the patients will be randomly divided into two groups with an equal number of patients in each group. The groups will then be randomized 1:1 to either start the IBS school within two to three weeks, or to receive the IBS Guidebook. The patients in the guidebook group will be offered to participate in the IBS school six months later, as part of the clinical routine at our unit (as requested by the ethics committee). The effects of the interventions on GI and psychological symptom severity, knowledge and quality of life will be assessed with validated questionnaires at baseline and 3 and 6 months after the intervention:

  1. Perceived knowledge about IBS
  2. IBS Severity Scoring System (IBS-SSS)
  3. IBS Quality of Life (IBSQOL)
  4. Visceral Sensitivity Index (VSI)
  5. The Hospital Anxiety and Depression Scale (HAD)

The interventions:

IBS school The IBS school is designed based on the self-efficacy theory , and the general theory of nursing. Moreover, the education is performed based on a biopsychosocial model considered to be important in functional GI disorders. The IBS-school consists of six sessions held once per week in a group setting with eight to ten patients in each group. Five different health care professionals (nurse, gastroenterologist, dietician, physiotherapist and psychologist) are involved in the education, in order to cover a wide spectra of issues related to IBS. Each of the professionals will hold one session for two hours where a lot of space is given for discussion in the group. This intervention has been described in detail previously (Ringström et. al. Submitted).

IBS Guidebook The IBS Guidebook consists of two booklets, written for IBS patients by one of the gastroenterologists in this study (MS). The booklets are detailed and cover the same areas of issues related to IBS as are covered in the structured education, namely pathophysiological mechanisms, GI and extra intestinal symptoms, the diagnostic workup, treatment options, food related issues, psychological and lifestyle factors.

Being tested
IBS school, IBS-guidebook
Keywords
Irritable bowel syndrome, Patient education
Medical subject headings
Irritable Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IBS schoolBehavioural

    Structured patient group education

  • IBS-guidebookBehavioural

    Written information - IBS-guidebook

Study groups in NCT00706758
Study groupRoleWhat they receive
1Active comparatorStructured patients group intervention - IBS school
Receives: Behavioral: IBS school
2Active comparatorWritten information - IBS-guidebook
Receives: Behavioral: IBS-guidebook

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effect on GI symptoms as measured by IBS-SSS

    Measured: Basleline and 3 and 6 months

Secondary outcomes (1)
  1. Effects on Quality of life (IBSQOL), Psychological symptoms (HAD), GI specific anxiety (VSI) and knowledge about IBS.

    Measured: Baseline, 3 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2008 (estimated)
  2. Study startAug 2004
  3. Primary completionJun 2008
  4. Study completionJun 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
143 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00706758
Sponsor's protocol ID
S487-02
Status last verified
Jun 2008
First submitted
25 Jun 2008
Last updated
20 Jul 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing IBS school and IBS-guidebook in people with Irritable Bowel Syndrome, run by Sahlgrenska University Hospital at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect on GI symptoms as measured by IBS-SSS (time frame: Basleline and 3 and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2011.

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